Label: CHILDRENS DIMETAPP COLD AND COUGH- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
- NDC Code(s): 51316-645-08
- Packager: CVS PHARMACY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 2, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 10 ml)
- Purposes
- Uses
-
Warnings
Do not use
- ▪
- to sedate a child or to make a child sleepy
- ▪
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- ▪
- heart disease
- ▪
- high blood pressure
- ▪
- thyroid disease
- ▪
- diabetes
- ▪
- trouble urinating due to an enlarged prostate gland
- ▪
- glaucoma
- ▪
- cough that occurs with too much phlegm (mucus)
- ▪
- a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
- ▪
- taking any other oral nasal decongestant or stimulant
- ▪
- taking sedatives or tranquilizers
When using this product
- ▪
- do not use more than directed
- ▪
- may cause marked drowsiness
- ▪
- avoid alcoholic beverages
- ▪
- alcohol, sedatives, and tranquilizers may increase drowsiness
- ▪
- be careful when driving a motor vehicle or operating machinery
- ▪
- excitability may occur, especially in children
- Directions
- Other information
- INACTIVE INGREDIENTS
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL
Compare to the active ingredients in Children’s Dimetapp® Cold & Cough*
NDC 51316-645-08
Children's
Cold
& CoughBrompheniramine maleate (Antihistamine)
Dextromethorphan HBr (Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)Relieves Nasal Symptoms
- •
- Stuffy Nose
- •
- Runny Nose
- •
- Sneezing
Plus Other Symptoms
- •
- Itchy, Watery Eyes
- •
- Cough
For Ages 6 Years and Over
Grape Flavor
Naturally and Artificially Flavored
8 FL OZ (236 ml)
Distributed by:
*This product is not distributed by Foundation Consumer Brands, LLC, the distributor of Children’s Dimetapp® Cold & Cough*.
-
INGREDIENTS AND APPEARANCE
CHILDRENS DIMETAPP COLD AND COUGH
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-645 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 2 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color PURPLE (purple liquid) Score Shape Size Flavor GRAPE (grape flavor and odor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-645-08 1 in 1 CARTON 02/20/2023 1 236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 02/20/2023 Labeler - CVS PHARMACY (062312574)
